Ann: Half Yearly Report and Accounts, page-17

Noda

I wasn’t commenting on the cost per patient for running the trial (which apparently will average over AU$400,000 per participant) but on the cost of drug manufacture.

The €4.15 million (AU$6.7m) Neuren is due to pay by March 2019 is said to be specifically for the manufacture of trofinetide under contract (see below). I was simply saying that AU$74,000 per patient (AU$6.7m/90) seems extraordinarily high to me for just 6 months drug supply, even allowing for back up supply, as suggested by Akki.

Hence my thinking that the AU$6.7m might indicate drug supply for both the Phase 3 Rett trial as well as a further Fragile X trial.

Is there anyone here with experience in drug manufacturing costs who can offer a more informed opinion?

At 30 June 2018, the Company had commitments under contracts for the manufacture of trofinetide amounting to approximately 1.9 million Euros and commitments under contracts for non‐clinical toxicology studies of approximately US$0.6 million. In July 2018, the Company made an additional commitment of 2.25 million Euros under a contract for the manufacture of trofinetide. The commitments are expected to become payable during the period to March 2019.

Half Year Report (p10)